Contract notice
Section I: Contracting
authority
I.1) Name and addresses
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital, Freeman Road, High Heaton
Newcastle-upon-Tyne
NE7 7DN
UK
Contact person: Ewan Bond
Telephone: +44 1912138916
E-mail: ewan.bond@nhs.net
NUTS: UKC22
Internet address(es)
Main address: https://www.newcastle-hospitals.nhs.uk
Address of the buyer profile: https://www.newcastle-hospitals.nhs.uk
I.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge at:
https://health-family.force.com/s/Welcome
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be sent electronically to:
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be sent to the abovementioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at:
https://health-family.force.com/s/Welcome
I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Health
Section II: Object
II.1) Scope of the procurement
II.1.1) Title
Digital Site File Application
II.1.2) Main CPV code
48000000
II.1.3) Type of contract
Supplies
II.1.4) Short description
The Clinical Research Directorate of the Newcastle upon Tyne NHS Foundation Trust currently maintains a large number of paper site files relating to study governance. Each site file contains documents such as study protocols, ethics regulatory approvals, delegation logs, training logs, consent forms and email correspondence. Each study will have between three and ten large lever arch site files and there are currently 1,400 studies in progress.<br/><br/>Many of the above documents are dynamic and version-controlled and paper copies of all changes must be retained for audit purposes. After study closure the files are sent to an off-site storage facility for periods ranging from five to 25 years depending on the nature of the study.<br/><br/>The Directorate wishes to implement a fully electronic site file for each study that will vastly reduce the use of paper documents, reduce the amount of staff time spent on printing and filing and eliminate the requirement to use an off-site storage facility to archive the documents of studies that have closed.<br/>The system must have the facility to:<br/><br/>a. Store and version-control documents<br/>b. Allow electronic signature of documents<br/>c. Be accessed and viewed remotely by non-trust employees with appropriate access controls <br/>d. Be aligned with Good Clinical Practice (GCP) expectations around controls, security, training and validation (Section 10.5.3 in the Grey Guide)<br/>e. Comply with Medicines & Healthcare products Regulatory Agency (MRHA) regulatory requirements<br/>f. Create an audit trail for all activities in the system.<br/>g. Create a comprehensive folder structure with sub-folders to facilitate storage and easy retrieval of documents<br/>h. Be configurable to organisational requirements<br/>j. Have search functionality for the location of documents with multiple options including pdf <br/>j. Exchange regulatory and source documentation with Sponsor/CTU<br/>k. Manage study timelines via alerts e.g. submission of annual reports<br/>l. Manage “live documents” e.g. amendment logs, delegation logs, AE/SAE logs
II.1.6) Information about lots
This contract is divided into lots:
No
II.2) Description
II.2.3) Place of performance
NUTS code:
UKC22
Main site or place of performance:
NE3 3HD
II.2.4) Description of the procurement
To procure a Digital Site File
II.2.5) Award criteria
Criteria below:
Quality criterion: Social Value
/ Weighting: 10
Quality criterion: Specification
/ Weighting: 70
Cost criterion: Commercial
/ Weighting: 20
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 60
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Open procedure
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
No
IV.2) Administrative information
IV.2.2) Time limit for receipt of tenders or requests to participate
Date:
10/11/2023
Local time: 17:00
IV.2.4) Languages in which tenders or requests to participate may be submitted
EN
IV.2.6) Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until:
28/02/2024
IV.2.7) Conditions for opening of tenders
Date:
09/10/2023
Local time: 14:00
Section VI: Complementary information
VI.1) Information about recurrence
This is a recurrent procurement:
Yes
Estimated timing for further notices to be published:
January 2028
VI.4) Procedures for review
VI.4.1) Review body
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Regent Point
NEWCASTLE UPON TYNE
NE7 7DN
UK
E-mail: procurement@noecpc.nhs.uk
Internet address(es)
URL: https://www.noecpc.nhs.uk
VI.5) Date of dispatch of this notice
09/10/2023